Micro- and Macro-Circulation in Cardiac Surgery Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Suspended
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Prediction of major morbidities by means of the variability of cardiovascular and hemodynamics markers
Study Overview
Brief Summary
The hypothesis under the study is that there could be a link between a dysfunction in peripheral microcirculation, sublingual microcirculation or cardiovascular control and the development of post cardiac surgery major morbidities (stroke, acute kidney injury, prolonged intubation, mediastinitis, surgical reopening, death).
The state of sublingual microcirculation, of peripheral microcirculation and cardiovascular control will be assessed in 100 patients undergoing cardiac surgery during general anesthesia before the intervention and at the end of the intervention at the arrival in post-surgery ICU by means of signal processing techniques.
The extracted markers will be used to assess a statistical prediction model of major morbidities.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •age >18 yrs
- •indication for a cardiac surgery intervention
- •spontaneous sinus rhythm
- •informed consent
Exclusion Criteria
- •know autonomic nervous systems pathologies or dysfunctions
- •pregnancy
Outcomes
Primary Outcomes
Prediction of major morbidities by means of the variability of cardiovascular and hemodynamics markers
Time Frame: 24 months
Statistical model assessment; time series variability analysis
Secondary Outcomes
No secondary outcomes reported
Investigators
Vlasta Bari
Assistant Professor, PhD
IRCCS Policlinico S. Donato